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Expert ID: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 735921 Georgia, USA

Expert in Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt

Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…

Expert ID: 733372 New York, USA

Expert in Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing

Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…

Expert ID: 733368 Massachusetts, USA

Expert in Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain

Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…

Expert ID: 730654 Canada

Expert in Electronic Material Processing, Chemical-Physical Analysis, Device Modeling, Biomedical Sensors

Expert has over thirty years experience in the design, micro-fabrication, analysis and modeling of electronic devices, transistors, and sensor arrays. He has extensive experience with the advanced processes for device fabrication: depositing the metal electrode and contact layers by sputtering,…

Expert ID: 729752 New Jersey, USA

Expert in Medical Device Design Control and Software Validation

Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…

Expert ID: 729236 California, USA

Expert in Medical Device Technology, Design and Manufacturing

Expert is a seasoned engineer with over 25 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and open…

Expert ID: 728303 California, USA

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A

Expert has been the CEO or chairman of seven medical device companies in four countries - four public, three private, and has been a member of the Board of Directors of 10 companies. He is an expert in areas of…

Expert ID: 728004 United Kingdom

Expert in Medical Devices and Biopharmaceuticals Design, Development, Manufacturing, and Business Development

He has a broad scientific and managerial experience of the healthcare industry, both public and private sectors, and both products and services . His experience encompasses the medical device, biopharmaceutical and health services sectors and the disciplines of research, development,…

Expert ID: 726193 New Jersey, USA

Expert in Medical Device Design and Analysis

He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several defibrillators. He was responsible for…

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